FDA 483 - Batzofin Fertility Services d.b.a. New York Fertility Services - April 29, 2019

Batzofin Fertility Services d.b.a. New York Fertility Services in New York received a Form 483 with four observations related to inadequate donor screening and eligibility determination for human cells, tissues, and cellular and tissue-based products (HCT/Ps). The firm failed to properly screen donors for communicable disease risks, including Zika virus, and did not have adequately defined and documented procedures for donor eligibility. Additionally, some donors with risk factors were deemed eligible, and specimens for testing were not collected at appropriate times.